But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-emp

But in McNellis v. Pfizer Inc., Simandle concluded that a state tort claim was not pre-empted because the FDA's regulations "empower drug manufacturers to enhance the labeling warnings beyond the approved text when new risks emerge."

In nearly two hours of oral argument on Monday, the three-judge panel appeared inclined to rule in favor of the drug manufacturers on the grounds that the FDA has explicitly rejected the plaintiffs' proposed warnings for Paxil, Zoloft and Prozac -- antidepressant drugs known as "selective serotonin re-uptake inhibitors," or SSRIs.

Six lawyers presented arguments, including a Justice Department lawyer arguing for the FDA who urged the court to side with Baylson and hold that such claims are pre-empted.

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